Electrical Stimulation for Nausea, Vomiting and Motion Sickness (PrimaBella and ReliefBand) and Other Selected Indications

Number: 0676

Policy

Aetna considers transcutaneous electrical acupoint stimulation (prescription version ReliefBand devices) medically necessary for the treatment of post-operative nausea and chemotherapy-induced nausea that is unresponsive to antiemetics and other conservative therapies.  

Aetna considers transcutaneous electrical acupoint stimulation (prescription version PrimaBella or ReliefBand devices) medically necessary for the treatment of hyperemesis gravidarum that is unresponsive to other conservative medical therapy (e.g., change in diet, ginger capsules, vitamin B6).

Aetna considers transcutaneous electrical acupoint stimulation experimental and investigational for the following indications because its effectiveness for these indications (not an all-inclusive list) has not been established:

  • Improvement of motor functions and self-care ability in children with cerebral palsy
  • Improvement of pregnancy rates in women undergoing in-vitro fertilization
  • Prevention of motion sickness
  • Reduction of incidence and severity of etomidate-induced myoclonus
  • Treatment of autism
  • Treatment of chronic fatigue syndrome
  • Treatment of chronic obstructive pulmonary disease
  • Treatment of hemodialysis-associated fatigue
  • Treatment of male infertility
  • Treatment of muscle spasticity following brain injury
  • Treatment of post-hemorrhoidectomy-associated pain and anxiety
  • Treatment of post-operative immune dysfunction in individuals with lung cancer
  • Treatment of tinnitus

Aetna considers transcutaneous neuromodulation and auricular electrostimulation experimental and investigational for nausea, vomiting, motion sickness and other indications because of insufficient evidence of effectiveness.

Note: Aetna does not cover over-the-counter disposable ReliefBand devices, which are used for the treatment of motion sickness, because they do not meet Aetna’s definition of durable medical equipment.

Background

Transcutaneous electrical acupoint stimulation, also known as acustimulation, has been proposed as a method of treating severe nausea and vomiting that does not respond to other conservative treatments. A watch-like device is placed on the wrist and provides very mild electrical impulses to stimulate the median nerve (which is an acupuncture point thought to be effective for the treatment of nausea and vomiting). Examples of devices used for this treatment include, but may not be limited to, the PrimaBella and ReliefBand.

The ReliefBand (Neurowave Medical Technologies, Chicago, IL) is a watch-like device worn on the ventral side of the wrist.  When activated, the device emits a low-level electrical current across 2 small electrodes on its underside, stimulating the median nerve (an acupuncture point).  The ReliefBand offers 5 stimulation levels from the rotary dial that one can control to provide maximum comfort and relief.  The non-invasive and drug-free ReliefBand is available by prescription for the treatment of nausea and vomiting (NV) due to pregnancy (PrimaBella, Alaven Pharmaceutical LLC, Marietta, GA), chemotherapy-induced NV, post-operative nausea and vomiting (PONV), and over-the-counter for the treatment of motion sickness.

Studies have shown that the ReliefBand is effective in treating chemotherapy-induced NV and as effective as antiemetic medications in managing NV following surgery. 

Lee and Done (1999) evaluated the effectiveness of non-pharmacologic techniques to prevent post-operative PONV by systematic review.  These studies included acupuncture, electroacupuncture, transcutaneous electrical nerve stimulation, acupoint stimulation, and acupressure.  The authors concluded that non-pharmacologic techniques were equivalent to commonly used antiemetic drugs in preventing vomiting after surgery.  Non-pharmacologic techniques were more effective than placebo in preventing NV within 6 hours of surgery in adults, but there was no benefit in children.

In a single-center, randomized, double-blind, placebo- and sham-controlled study, White et al (2002) compared the effectiveness of the ReliefBand to ondansetron when utilized alone or in combination for preventing PONV following plastic surgery (n = 120).  Patients were randomly assigned to 3 prophylactic antiemetic treatment regimens with routine low-dose droperidol prophylaxis:
  1. ondansetron (n = 40): 4 mg intravenous (I.V.) ondansetron and a sham ReliefBand;
  2. acustimulation (n = 40): 2 ml I.V. saline and an active ReliefBand; and
  3. combination (n = 40): 4 mg I.V. ondansetron and an active ReliefBand. 

The incidences of PONV, as well as the need for "rescue" antiemetics, were determined at specific time intervals for up to 72 hours after surgery.  The outcome variables assessed included recovery times, quality of recovery score, time to resumption of normal diet, and patient satisfaction with the prophylactic antiemetic therapy.  Use of the ReliefBand in combination with ondansetron significantly reduced nausea (20 versus 50 %), vomiting (0 versus 20 %), and the need for rescue antiemetics (10 versus 37 %) compared with ondansetron alone at 24 hours after surgery.  Furthermore, the ability to resume a normal diet (74 versus 35 %) within 24 hours after surgery was significantly improved when the ReliefBand was used to supplement ondansetron (versus ondansetron alone).  Finally, the quality of recovery (90 +/- 10 versus 70 +/- 20) and patient satisfaction (94 +/- 10 versus 75 +/- 22) scores were significantly higher in the combination group than the ondansetron group.  There were no significant differences between the ReliefBand and ondansetron when administered as adjuvants to droperidol for antiemetic prophylaxis. The authors concluded that the ReliefBand compared favorably to ondansetron when used for prophylaxis against PONV.



In a randomized, double-blind, placebo- and sham-controlled study, Coloma et al (2002) compared the ReliefBand with ondansetron (Zofran) for the treatment of PONV after outpatient laparoscopic surgery (n = 268).  All patients received antiemetic prophylaxis with metoclopramide, 10 mg I.V. or droperidol, 0.625 mg I.V. after induction of anesthesia.  A total of 90 patients developed PONV in the recovery units and were randomized to 1 of 3 treatment groups:
  1. the ondansetron group received 4 mg I.V. ondansetron and a sham ReliefBand;
  2. the acustimulation group received 2 ml I.V. saline and a ReliefBand; and
  3. the combination group received 4 mg I.V. ondansetron and a ReliefBand. 

A rescue antiemetic (10 mg I.V. metoclopramide) was administered only if the PONV symptoms persisted for 15 minutes or longer after initiating the treatment.  A blinded observer recorded the recovery times, emetic symptoms, rescue antiemetics, maximum nausea scores, complete response to study treatment, and time to achieve discharge criteria.  Post-discharge side effects, as well as patient satisfaction and quality of recovery scores, were assessed at 24 and 72 hours after surgery.  The combination group had a significantly higher complete response rate than the acustimulation group (73 versus 40 %).  In addition, fewer patients in the combination group experienced subsequent emetic events (8 compared to 18 in the acustimulation group).  However, there were no significant differences between the 3 groups with respect to patient satisfaction and quality of recovery scores. The authors concluded that acustimulation with the ReliefBand can be used as an alternative to ondansetron for the treatment of established PONV.

Habib and colleagues (2006) examined whether transcutaneous acupoint electrical stimulation with the ReliefBand can prevent NV during and after cesarean delivery under spinal anesthesia.  These investigators randomized 94 patients undergoing cesarean delivery with spinal anesthesia to receive the ReliefBand at the P6 point (active group) or an active ReliefBand applied to the dorsum of the wrist (sham control group).  The ReliefBand was applied 30 to 60 mins pre-operatively and left in place for 24 hours.  There was no statistically significant difference between the active and sham control groups in the incidence of intra-operative/post-operative nausea (30 % versus 43 %/23 % versus 41 %), vomiting (13 % versus 9 %/26 % versus 37 %), need for rescue antiemetics (23 % versus 18 %/34 % versus 39 %), or complete response (55 % versus 57 %/51 % versus 34 %).  There was also no difference between the 2 groups in nausea scores, number of vomiting episodes, or patient satisfaction with PONV management.

In a randomized controlled study (n = 105), White et al (2005) reported that acustimulation with the ReliefBand was most effective in reducing PONV and improving patients' satisfaction with their antiemetic therapy when it was administered after surgery.

However, a Cochrane review on acupuncture-point stimulation (needles, electrical stimulation, magnets, or acupressure) for chemotherapy-induced NV (Ezzo et al, 2006) reported that non-invasive electrostimulation appears unlikely to have a clinically relevant impact when patients are given state-of-the-art pharmacological antiemetic therapy.

PrimaBella (Alaven Pharmaceutical LLC, Marietta, GA) is a neuromodulatory device that utilizes the same technology as the ReliefBand.  It is intended for use in the treatment of NV due to pregnancy.  

Slotnick (2001) evaluated the safety and effectiveness of P-6 acustimulation for the relief of NV associated with early pregnancy in 41 patients.  Pre-treatment nausea severity, post-treatment nausea relief and device effectiveness were patient-rated using a 1 to 5 scale.  All neonates were evaluated for congenital abnormalities.  Pre-treatment nausea severity scores for treated patients averaged 4.2, with most severe and debilitating nausea rated 5.  Post-treatment device effectiveness averaged 4.2, with significant or complete relief rated 5.  Device ease of use averaged 4.3, with very easy to use rated 5.  No congenital abnormalities were found.  The authors concluded that because current pharmacologic treatments for nausea in early pregnancy are not consistent, efficacious or without un-wanted side effects or increased teratogenic risks, acustimulation of P-6 in pregnancy may prove to be a significant therapeutic alternative to current pharmacologic treatments for nausea in early pregnancy. 

The American College of Obstetrics and Gynecology (ACOG, 2004) recommend a step-wise approach to alleviating NV in pregnancy, beginning with prevention at the time of conception.  Two studies found that women who take a multi-vitamin at the time of conception were less likely to need medical attention for vomiting.  While there is little published evidence regarding the efficacy of dietary changes for prevention or treatment of NV of pregnancy, a small study showed that protein meals were more likely to relieve NV of pregnancy than carbohydrate and fatty meals.  Other conservative treatments recommended by ACOG included ginger capsules and electrical stimulation or acupressure at the P6 (or Neguian) point on the inside of the wrist.  Women with more complicated NV of pregnancy may need pharmacologic therapy.  While many conventional antiemetics have been used for NV of pregnancy, it is important to note that no drug has been approved by the FDA for the treatment of NV in pregnancy since Benedictine (an antiemetic no longer available in the U.S. but still widely used in Europe). 

In the largest controlled clinical study of the Relief Band for motion sickness published to date (n = 77), Miller and Muth (2004) examined whether acupressure and acustimulation can prevent motion sickness, taking into consideration whether or not the acupressure and acustimulation are administered properly.  These investigators found that neither band (the Acuband or the ReliefBand) nor placebo prevented the development of motion sickness, regardless of whether the bands were used correctly or incorrectly.

Zheng et al (2014) noted that the latest meta-analysis demonstrated that acupuncture improves pregnancy rates among women undergoing in-vitro fertilization-embryo transfer (IVF-ET), and surface acupoint stimulation, such as transcutaneous electrical acupoint stimulation (TEAS), may have the same or better potential.  To explore the effect of TEAS on the clinical pregnancy rate (CPR) and live-birth rate (LBR) compared with real acupuncture and controls in women undergoing IVF, a multi-center, randomized controlled trial will be conducted.  The inclusion criteria are the following: infertile women less than 40 years of age undergoing a fresh IVF or intra-cytoplasmic sperm injection cycle, and the study will be restricted to women with the potential for a lower success rate as defined by 2 or more previous unsuccessful ETs (fresh or frozen).  Those who have severe illnesses possibly precluding IVF or pregnancy, have FSH levels greater than 20 IU/L, received donor eggs, had been previously randomized for this study or had undergone acupuncture (in any modality) as infertility treatment will be excluded.  The subjects will be randomly assigned to the TEAS group (IVF + TEAS), the electro-acupuncture (EA) group (IVF + EA), or the control group (only IVF).  A total sample size of 2,220 women is needed to detect differences in CPR among the 3 groups.  Transcutaneous electrical acupoint stimulation or EA treatments will start once every 2 or 3 days from day 3 of menstruation in the ovarian stimulation cycle until the day of ET.  The parameters of TEAS or EA will be the following: a frequency of 2/100 Hz, a moderate electrical current of 3 to 5 mA for TEAS and 0.8 to 1.0 mA for EA.  The primary outcome is CPR; secondary outcomes are LBR, the number of oocytes aspirated and the total gonadotropin dose used in the stimulation cycle.  The authors concluded that this study will provide significant evidence for using a new method (TEAS) in IVF.

Zhao et al (2015) evaluated the clinical safety and effectiveness of TEAS for the treatment of muscle spasticity after brain injury. A total of 60 patients with muscle spasticity after brain injury were randomized to the following 3 groups: 100, 2, and 0 Hz (sham) TEAS. The acupoints Hegu (LI4) -- Yuji (LU10) and Zusanli (ST36) -- Chengshan (BL57) on the injured side were stimulated at 0, 2, or 100 Hz; 5 times per week for 4 weeks. Patients were followed-up for 1 and 2 months after the treatments. The effects of the treatments on muscle spasticity at the wrist, thumb, the other 4 fingers, elbow, shoulder, knee, and ankle were evaluated by the Modified Ashworth Scale, and the effects on disability were assessed by the Disability Assessment Scale. The walking capability was evaluated by the Holden functional ambulation classification score. The overall performance was assessed by the Global Assessment Scale score and the improved Barthel Index.  The safety of the treatments administered was also monitored.  The wrist spasticity was significantly reduced from baseline at weeks 2, 3, and 4 of treatment and at the 1- and 2-month follow-up visits in the 100 Hz group (p < 0.01). Compared with 2 Hz or sham TEAS, 100 Hz TEAS decreased wrist spasticity at weeks 2, 3, and 4 of treatment and 1 month after treatment (p < 0.001). The other end-points were not affected by the treatments. No treatment-emergent adverse events were reported during treatments and follow-up visits. The authors concluded that TEAS appears to be a safe and effective therapy to relieve muscle spasticity after brain injury, although large-scale studies are needed to further verify the findings.

Transdermal Neuromodulation

Transdermal neuromodulation is a variation of transcutaneous electrical acupoint stimulation. It is proposed as treatment for chemotherapy-induced nausea and vomiting. An example of a device used for this treatment is the Nomete, a watch-like device that generates a programmed pulse to stimulate the median nerve on the underside of the wrist

Auricular Electrostimulation

Auricular electrostimulation (also referred to as auricular electroacupuncture or pulsed stimulation) is the application of electrical impulses/stimulation to acupuncture points on the ear. It is theorized that stimulation of the corresponding acupuncture points will relieve pain in various locations in the body. Examples of this type of device include, but may not be limited to, the P-Stim and NIPP device which are disposable, pre-programmed units worn behind the ear and connected to acupuncture needles.

Treatment of Chronic Obstructive Pulmonary Disease

In a prospective, single-blind, randomized, placebo-controlled study, Liu and associates (2015) evaluated the clinical effect of transcutaneous electrical nerve stimulation over acupoints (acu-TENS) on patients with stable chronic obstructive pulmonary disease (COPD). A total of 50 patients with stable COPD enrolled in the study.  Patients were randomly assigned to 1 of 2 groups:
  1. the acu-TENS group (n = 25), who underwent acu-TENS over acupoints of bilateral EX-B-1(Dingchuan), BL-13 (Feishu), BL-23 (Shenshu), ST-36 (Zusanli), and
  2. the placebo acu-TENS control group (n = 25), who had the same electrode placement but no electrical output.  

Treatments were performed for 40-min sessions every 2 days for 4 weeks.  Lung function (forced expiratory volume in 1 second, percentage predicted (FEV(1)% predicted); forced vital capacity, percentage predicted (FVC% predicted), 6-minute walk distance (6MWD) and oxygen saturation (SpO(2)), COPD assessment test (CAT), and Dyspnea Visual Analogue Scale (DVAS) were assessed before and after the intervention.  Compared to control group, FEV(1)% predicted was improved and CAT score was decreased significantly in the acu-TENS group after treatment (p < 0.05).  The DVAS score decreased significantly in the acu-TENS group (p = 0.039), with a slight but insignificant improve in 6MWD, SpO(2), and FVC% predicted after treatment.  The authors concluded that the Acu-TENS over acupoints of bilateral EX-B-1 (Dingchuan), BL-13 (Feishu), BL-23 (Shenshu), and ST-36 (Zusanli) improved FEV(1)% predicted and reduced DVAS and CAT scores on patients with stable COPD.  They stated that this may be a novel treatment strategy in COPD.

Treatment of Post-Operative Immune Dysfunction in Individuals with Lung Cancer

Wu and colleagues (2016) noted that an imbalance in the various T lymphocytes, including T-helper (Th)1, Th2 and Th17 cells, and regulatory T (Treg) cells, has been associated with immune dysfunction, and may occur following thoracotomy of patients with lung cancer. The use of transcutaneous acupoint electrical stimulation (TAES) has previously been demonstrated to exert immune-regulatory effects; therefore, the present study aimed to examine if TAES was able to attenuate post-operative immune suppression in patients with lung cancer.  Thoracic surgical patients with lung cancer (n = 27) underwent TAES (frequency, 2/100 Hz; intensity, 4 to 12 mA) at the bilateral large intestine 4, pericardium 6, small intestine 3 and San Jiao 6 acupuncture points for 30 mins, prior to incision, and at 20, 44, 68, 92 and 116 hrs following thoracotomy.  The number of Th1, Th2, Th17 and Treg cells, and the protein and mRNA expression levels of related cytokines were measured by flow cytometry, ELISA and polymerase chain reaction, respectively.  The balance of Th1, Th2, Th17 and Treg cells in the peripheral blood of patients with lung cancer was disrupted following thoracotomy; TAES administration increased the percentage of Th1 and Th17 cells, the protein expression levels of interleukin (IL)-2 and interferon-γ, the mRNA expression levels of T-bet and RAR-related orphan receptor-γt, and decreased the percentage of Th2 cells, IL-10 protein expression levels, and GATA binding protein 3 mRNA expression levels.  The results of the present study demonstrated that TAES was able to partially attenuate the post-operative immune depression of patients with lung cancer, by regulating the balance of Th1, Th2, Th17 and Treg cells, and the expression levels of related cytokines and transcription factors; therefore, TAES may be considered to be a promising strategy for treating post-operative immune dysfunction in patients with lung cancer.

Hu and colleagues (2017) examined the effect of percutaneous electrical stimulation on chemotherapy-induced bone marrow suppression in patients with lung cancer.  From December 2014 to August 2015, a total of 191 non-small cell lung cancer (NSCLC) patients with chemotherapy naive were randomly divided into control group, medication group, and TEAS group.  Patients with the control group received routine nursing care, the medication group was treated by oral administration of prophylactic agents, and TEAS group received electrical stimulation of acupoints including Dazhui (DU14), Geshu (BL17), Zusanli (ST36), Sanyinjiao (SP6), and Hegu (LI4).  The primary end-point was the blood routine indexes and secondary end-point was the degree of comfort.  The white blood cell in the TEAS group was significantly higher than the control group on day 8 and day 14 (p < 0.05).  The platelet count in the TEAS group was significantly higher than control group on day 5, day 8 and day 11 (p < 0.05).  The comfort score in the TEAS group was significantly higher than control group on day 8 (p < 0.05).  The authors concluded that TEAS could prevent chemotherapy-induced bone marrow suppression in patients with NSCLC and ensure a smooth continuation of chemotherapy.  Moreover, they stated that a larger, multi-center study is needed to confirm the effects of TEAS.

Treatment of Tinnitus

Li and co-workers (2015) noted that subjective tinnitus is a phantom sensation experienced in the absence of any source of sound. Its mechanism remains unclear, and no approved drugs are available.  Vagus nerve stimulation (VNS) is an exciting new method to treat tinnitus, but direct electrical stimulation of the cervical vagus has disadvantages.  This randomized controlled clinical trial aims to overcome these limitations by stimulating the auricular branch of vagus nerve (ABVN) on the outer ear.  Since the ABVN is the only peripheral branch of the vagus nerve distributed on the ear's surface, it should be possible to achieve analogous efficacy to VNS by activating the central vagal pathways.  However, researches have indicated that the curative effect lies in a combination of auditory and vagal nerve stimulation.  Moreover, from traditional Chinese theory, auricular acupoints used to treat tinnitus are mainly in the regions supplied by the ABVN.  Whether stimulation at the auricular acupoints is due to unintentional stimulation of vagal afferent fibers also needs evidence.  A total of 120 subjects with subjective tinnitus are randomized equally into 4 groups:
  1. electrical stimulation at auricular acupoints (CO10, CO11, CO12, and TF4) innervated by the ABVN;
  2. electrical stimulation at auricular acupoints (CO10, CO11, CO12, and TF4) innervated by ABVN pairing tones;
  3. electrical stimulation at auricular acupoints innervated by non-ABVN pairing tones; and
  4. electrical acupuncture.  

Patients will be treated for 30 minutes every other day for 8 weeks.  The primary outcome measure is the Tinnitus Handicap Inventory.  The secondary outcome measure combines a visual analog scale (VAS) to measure tinnitus disturbance and loudness with the Hospital Anxiety and Depression Scale.  Assessment is planned at baseline (before treatment) and in the 4th and 8th week, with further follow-up visits after termination of the treatment at the 12th week.  Any adverse events will be promptly documented.  The authors stated that completion of this trial will help to confirm whether ABVN or the combination of ABVN and sound stimulus plays a more important role in treating tinnitus.  Moreover, the result of this clinical trial will enhance our understanding of specific auricular acupoints.

Hemodialysis-Associated Fatigue

In a randomized control trial (RCT), Hadadian and associates (2016) evaluated the effects of TEAS on fatigue among end-stage renal disease (ESRD) patients receiving hemodialysis treatment.  This study was conducted over a 5- month period in 2009.  A total of 56 patients who had undergone hemodialysis and meeting the inclusion criteria, were divided into 2 groups by simple random sampling:
  1. TEAS (n = 28) and
  2. TEAS-Sham (n = 28). 

Data were gathered through the Brief Fatigue Inventory (BFI), entered into SPSS-16 software and analyzed by descriptive and inferential statistics.  Out of 56, 38 patients (67.9 %) were men and 45 (80.4 %) were married.  The mean and standard deviation (SD) of age were 52.29 ± 15.26 years.  The inferential tests showed no differences in the clinical and the demographic characteristics of patients among 2 groups (p > 0.05).  The mean rank of fatigue score in TEAS and TEAS-Sham groups was 30.68 and 26.32, respectively (p = 0.317) at the first of study.  The results of the Mann-Whitney U-test indicated that there were significant differences between the TEAS and Sham groups after intervention (p = 0.002).  The authors concluded that these findings revealed that application of the TEAS on these acupoints produced a better recovery rate of fatigue in TEAS group than Sham group after a course of 10 session intervention.  Furthermore, they stated that additional studies are needed to consolidate a standardized method and maximize the effectiveness of TEAS.  They noted that future research should include the identification of the most effective acupoints and the mechanism behind it.  In addition, other variables such as optimal electrode size, electrical power and frequency, waveform, stimulation duration should be examined.

This study had 2 major drawbacks:

  1. Although, the results showed that the effects of TEAS on the improvement of fatigue in hemodialysis patients, the sample was drawn from 2 dialysis centers in Ahvaz, southwest of Iran.  Generalizability of these findings to other samples of dialysis patients from other geographical areas in Iran cannot be ensured,
  2. non-registry in Iranian Registry of Clinical Trials (IRCT), because this project was conducted in 2009, and in that time, the registration was optional for the universities, so, this research has not been enrolled in the IRCT.

Post-Hemorrhoidectomy-Associated Pain and Anxiety

In a randomized-controlled trial (RCT) with 5 repeated measures, Yeh and colleagues (2018) examined the effects of TAES intervention on post-operative pain, anxiety, and heart rate variability (HRV) in patients who received a hemorrhoidectomy.  The TAES group (n = 39) received 4 20-min sessions of electrical stimulation at chengshan (BL57) and erbai (EX-UE2) after hemorrhoidectomy, whereas the control group (n = 41) did not.  Data were collected using VAS, State Anxiety Inventory (STAI), and HRV physiological signal monitor; TAES resulted in a significant group difference in pain scores, anxiety levels, and some HRV parameters.  The authors concluded that these findings indicated that TAES could aid in reducing pain and anxiety associated with hemorrhoidectomy.  The main drawback of this study was its relatively small sample size (n = 39 for the TAES group). 

Furthermore, an UpToDate review on “Surgical treatment of hemorrhoidal disease” (Rivadeneira and Steele, 2017) does not mention transcutaneous electrical acupoint stimulation as a management tool.

Improvement of Motor Functions and Self-Care Ability in Children with Cerebral Palsy

In a preliminary, prospective, cohort, multi-center study, Zhang and colleagues (2018) examined the effects of TEAS in improving motor functions and self-care abilities in children with cerebral palsy (CP) in their early childhood (aged 2 to 6 years).  A total of 23 children were included in the study and randomly assigned to a control group ([CG] n = 11) or a therapeutic group ([TG] n = 12).  In the TG, children were treated with TEAS (Shousanli [LI10] and Waiguan [SJ5]) plus the exercise therapy, while in the control group, they were treated with sham TEAS plus exercise therapy.  Therapies were performed 5 days per week for 8 weeks.  The Gross Motor Function Measure (GMFM) and the Functional Independent Measurement for children (WeeFIM) were used to evaluate motor functions and self-care abilities before and after the therapies.  Greater improvements were observed in the TG concerning all the measurements, although without statistical differences.  The increments of the GMFM score and the WeeFIM motor, self-care and total scores were 36.08 ± 18.34 (26 %), 16.17 ± 8.21 (33 %), 7.67 ± 3.42 (40 %) and 20.33 ± 10.08 (28 %) in the TG, while 22.73 ± 16.54 (17 %), 9.09 ± 9.43 (19 %), 5.64 ± 6.73 (29 %) and 12.82 ± 11.77 (18 %) in the CG, respectively.  No statistically significant correlations were shown between functional improvements and the demographics in the TG or the CG.  The GMFM improvement was not statistically correlated with the improvements of the WeeFIM motor, self-care or total scores.  However, the WeeFIM motor, self-care and total score were significantly positively correlated with one another in both groups (p < 0.01).  No adverse effect was recorded during the study.  The authors concluded that TEAS may be effective in improving motor functions and self-care abilities in children with CP, in addition to conventional exercise therapy.  These researchers stated that larger samples are needed to confirm the efficacy of TEAS in improving motor functions and self-care abilities in children with CP.

Reduction of Incidence and Severity of Etomidate-Induced Myoclonus

Lv and colleagues (2018) stated that myoclonus is an undesirable phenomenon that occurs after induction of general anesthesia using etomidate.  Opioids such as sufentanil are considered effective pre-treatment drugs for myoclonus inhibition, although high doses are needed; TAES exhibits analgesic effects, promotes anesthetic effects, decreases the dose of anesthetic drugs, and increases endogenous opioid peptide levels.  In a double-blind RCT, these investigators examined the effects of TAES combined with low-dose sufentanil pre-treatment on the incidence and severity of etomidate-induced myoclonus in patients undergoing elective hysteroscopy.  A total of 172 patients (American Society of Anesthesiologists [ASA] class I to II; age of 20 to 55 years) scheduled to undergo elective hysteroscopy were randomized into the following groups (n = 43 each): control (false TAES followed by saline injection after 30 mins), TAES (TAES followed by saline injection after 30 mins), sufentanil [false TAES followed by low-dose sufentanil (0.1 μg/kg) injection after 30 mins], and sufentanil plus TAES (TAES followed by low-dose sufentanil injection after 30 mins).  In all groups, general anesthesia was induced by etomidate 0.3 mg/kg after sufentanil or saline injection.  The incidence and severity of myoclonus were assessed for 2 mins after etomidate administration.  The VAS scores for pain at 1 hour after surgery were recorded.  The HR, mean arterial pressure (MAP), and peripheral capillary oxygen saturation (SPO2) were recorded before pre-medication, after etomidate injection, after uterus expansion, and after recovery from anesthesia.  The incidence of myoclonus was highest in the control group (88.3 %), followed by TAES (74.4 %), sufentanil (60.4 %), and TAES plus sufentanil (48.8 %) groups.  Thus, the incidence was significantly higher in the control and TAES groups than in the sufentanil and TAES plus sufentanil groups.  Grade 3 myoclonus occurred in 30.2 %, 9.3 %, 11.6 %, and 9.3 % patients in the control, TAES, sufentanil, and TAES plus sufentanil groups, respectively, with significant differences between the control group and the other 3 groups.  Furthermore, the post-operative VAS scores for pain were significantly lower in the TAES, sufentanil, and TAES plus sufentanil groups compared with those in the control group.  There were no significant differences in any other parameters among groups.  The authors concluded that these findings suggested that TAES combined with low-dose opioids such as sufentanil could decrease the incidence and severity of etomidate-induced myoclonus.  The effectiveness of TAES alone for lowering the incidence and severity of etomidate-induced myoclonus needs to be further investigated in well-designed studies.

Treatment of Autism

Zhang and colleagues (2017) examined the efficacy of TEAS in treating children with autism spectrum disorders (ASD).  A total of 41 autistic children receiving rehabilitation training were randomized into TEAS (n = 21) and control (n = 20) groups.  The control group only received rehabilitation training; the TEAS group received both rehabilitation training and TEAS treatment [2 Hz/15 Hz alternating frequencies through 2 pairs of skin electrodes placed at Hegu (LI 4)-Neiguan (PC 6) on unilateral side, and Zusanli (ST 36)-Sanyinjiao (SP 6) on the contralateral side].  The treatment was given 30 mins per day for 12 weeks.  The outcome assessment was quantified with a series of rating scales including Autism Behavior Checklist (ABC), Childhood Autism Rating Scale (CARS) and Parent Symptom Questionnaire (PSQ).  The TEAS group showed more significant improvement than the control group in ABC (p < 0.01); 38.1 % effective rate (8/21) was observed in the TEAS group compared to 5.0 % (1/20) in the control group (p < 0.05).  The CARS scores of both groups were reduced (p < 0.0001) after treatment.  The TEAS group showed significantly lower score compared to the control group (p < 0.0001).  There was a reduced PSQ score in both TEAS and control groups (p < 0.001) after treatment.  Transcutaneous electrical acupoint stimulation showed better effect in children under age of 6 years with moderate or severe autistic symptoms.  The authors concluded that TEAS intervention could improve autistic symptoms.  These preliminary findings need to be validated by well-designed studies with larger sample size and long-term follow-up.

Treatment of Chronic Fatigue Syndrome

In a RCT, Li and colleagues (2017a) evaluated the clinical therapeutic effects and safety of chronic fatigue syndrome (CFS) treated with TEAS on the conception vessel and the governor vessel.  A total of 89 patients with CFS were randomized into an observation group (46 cases) and a control group (43 cases).  In the observation group, TEAS was applied at Dazhui (GV 14) and Mingmen (GV 4), Shenque (CV 8) and Guanyuan (CV 4) [the current intensity: (14 ± 2) mA].  In the control group, the simulated TEAS was applied at the same acupoints as the observation group (the current intensity: 1 mA).  The treatment was given for 30 mins, once-daily, 5 times a week and the treatment of 4 weeks was as 1 session in the 2 groups.  One session of treatment was required.  Before treatment and at the end of 1 session of treatment, the fatigue severity scale (FSS) was adopted to evaluate the fatigue symptoms and the somatic and psychological health report (SPHERE) was adopted to evaluate the potential symptoms and observe the safety of TEAS therapy.  At the end of treatment, FSS score and SPHERE score in the control group were not significantly different as compared with those before treatment (both p > 0.05); FSS score and SPHERE score in the observation group were reduced significantly as compared with those before treatment (both p < 0.01); FSS score and SPHERE score in the observation group were reduced apparently as compared with those in the control group (both p < 0.001).  In the entire process of treatment with TEAS, no any adverse reaction occurred.  The authors concluded that TEAS on the conception vessel and the governor vessel relieved fatigue symptoms and the potential symptoms in the patients with CFS; they noted that TEAS is a safe therapy.  These preliminary findings need to be validated by well-designed studies with larger sample size and long-term follow-up.

Treatment of Male Infertility

Li and co-workers (2017b) examined the feasibility, safety and clinical effect of mid-frequency TEAS combined with oral tamoxifen (TAM) in the treatment of oligoasthenozoospermia.  These researchers randomly assigned 120 patients with idiopathic oligoasthenozoospermia to receive oral TAM, mid-frequency TEAS, or TAM+TEAS, all 8 weeks.  Before and after treatment, these investigators recorded the semen volume, total sperm count, sperm concentration, sperm motility, percentage of progressively motile sperm (PMS), and the levels of follicle-stimulating hormone (FSH), luteotrophic hormone (LH) and testosterone (T) in the peripheral serum and compared these parameters among the 3 groups of patients.  Compared with the baseline, none of the patients showed significant improvement in the semen volume (p > 0.05); but all exhibited remarkably elevated levels of serum FSH, LH and T after treatment (p <0.05); TAM significantly improved the total sperm count (25.16 ± 2.05 versus 42.65 ± 5.78 ×106, p <0.05) and sperm concentration (12.15 ± 2.51 versus 24.31 ± 2.59 ×10⁶/ml, p < 0.05), but not total sperm motility (21.78 ± 8.81 versus 22.61 ± 5.75 %, p > 0.05) or PMS (15.87 ± 7.81 versus 16.76 ± 5.86 %, p > 0.05); TEAS markedly increased total sperm motility (24.81 ± 8.27 versus 32.43 ± 4.97 %, p < 0.05) and PMS (19.71 ± 9.15 versus 27.17 ± 5.09 %, p < 0.05), but not the total sperm count (23.23 ± 3.14 versus 25.87 ± 4.96 x 106, p > 0.05) or sperm concentration (11.27 ± 2.24 versus 14.12 ± 2.47 ×10⁶/ml, p > 0.05); TAM+TEAS, however, improved not only the total sperm count (26.17 ± 5.05 versus 51.14 ± 3.69 ×106, p < 0.05) and sperm concentration (12.78 ± 2.41 versus 27.28 ± 1.98 ×10⁶/ml, p < 0.05), but also total sperm motility (23.89 ± 9.05 versus 37.12 ± 5.33 %, p < 0.05) and PMS (17.14 ± 8.04 versus 31.09 ± 7.12 %, p < 0.05).  The total effectiveness rate was significantly higher in the TAM+TEAS group than in the TAM and TEAS groups (97.5 % versus 72.5 % and 75.0 %, p < 0.05).  The authors concluded that mid-frequency TEAS combined with tamoxifen can significantly improve semen quality and increase sex hormone levels in patients with idiopathic oligoasthenozoospermia.  The effectiveness of TEAS alone for the treatment of oligoasthenozoospermia needs to be further investigated in well-designed studies.

Furthermore, an UpToDate review on “Treatments for male infertility” (Anawalt and Page, 2018) does not mention transcutaneous acupoint electrical stimulation as a therapeutic option.

Table: CPT Codes / HCPCS Codes / ICD-10 Codes
Code Code Description

Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":

CPT codes not covered for indications listed in the CPB:

97813 Acupuncture, 1 or more needles; with electrical stimulation, initial 15 minutes of personal one-on-one contact with patient
+97814     with electrical stimulation, each additional 15 minutes of personal one-on-one contact with the patient, with re-insertion of needle(s) (List separately in addition to code for primary procedure)

Other CPT codes related to the CPB:

97014 Application of a modality to one or more areas; electrical stimulation (unattended)
97032 Application of a modality to one or more areas; electrical stimulation (manual), each 15 minutes

HCPCS codes covered if selection criteria are met:

E0765 FDA approved nerve stimulator, with replaceable batteries, for treatment of nausea and vomiting

HCPCS codes not covered for indications listed in the CPB:

S8930 Electrical stimulation of auricular acupuncture points; each 15 minutes of personal one-on-one contact with the patient

Other HCPCS codes related to the CPB:

G0283 Electrical stimulation (unattended), to one or more areas for indication(s) other than wound care, as part of a therapy plan of care

ICD-10 codes covered if selection criteria are met:

K91.0 Vomiting following gastrointestinal surgery
O21.0 - O21.9 Excessive vomiting in pregnancy
R11.0 - R11.2 Nausea and vomiting
T45.1X5+ Adverse effect of antineoplastic and immunosuppressive drugs [post-operative nausea and chemotherapy-induced nausea]

ICD-10 codes not covered for indications listed in the CPB:

C34.00 - C34.92 Malignant neoplasm of bronchus and lung
D02.20 - D02.22 Carcinoma in situ of bronchus and lung
F84.0 - F84.9 Pervasive developmental disorders
G25.3 Myoclonus [etomidate-induced]
G80.0 - G80.9 Cerebral palsy
H93.11 - H93.19 Tinnitus
H93.A1 - H93.A9 Pulstile tinnitus
J44.0 - J44.9 Other chronic obstructive pulmonary disease
M62.40 - M62.49 Contracture of muscle
N46.01 - N46.9 Male infertility
N97.0 - N97.9 Female infertility
R53.82 Chronic fatigue, unspecified [hemodialysis-associated]
R53.83 Other fatigue [hemodialysis-associated]
S02.0XX+ - S02.92X+ Fracture of skull and facial bones
S06.0X0+ - 06.9X9+ Intracranial injury
T75.3XX+ Motion sickness
Z31.83 Encounter for assisted reproductive fertility procedure cycle
Z31.89 Encounter for other procreative management

The above policy is based on the following references:

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